Brand Names:

Mifeprex®

IMPORTANT WARNING:

Serious side effects such as very heavy vaginal bleeding or severe or life-threatening infection can occur in a few patients when mifepristone is used to end a pregnancy. In a small number of patients, mifepristone may not end the pregnancy. If this happens, you may need to have surgery to end your pregnancy. If mifepristone does not end the pregnancy and you do not have surgery to end the pregnancy, there is a risk of birth defects in the baby.Tell your doctor if you have or have ever had bleeding problems, an ectopic pregnancy ('tubal pregnancy' or pregnancy outside the uterus), anemia (less than normal number of red blood cells), or if you are taking anticoagulants ('blood thinners') such as warfarin (Coumadin), heparin, or aspirin. If you experience very heavy vaginal bleeding after treatment with mifepristone, such as soaking through two thick full-size sanitary pads every hour for two continuous hours, call your doctor immediately or seek emergency medical care. You also should call your doctor immediately or seek emergency care if you experience fever greater than 100.4°F that lasts for more than 4 hours, severe pain or tenderness in the area below the waist, chills, a fast heart beat, shortness of breath, dizziness, fainting, or blurred vision after treatment with mifepristone. Your doctor will give you the manufacturer's medication guide to read before you begin treatment with mifepristone.You will also need to sign a patient agreement before taking mifepristone. Tell your doctor if you have questions about treatment with mifepristone or if you can not follow the guidelines in the patient agreement.Talk to your doctor and decide whom to call and what to do in case of an emergency after taking mifepristone. Take your medication guide with you if you visit an emergency room or seek emergency medical care.Keep all appointments with your doctor.Talk to your doctor about the risks of taking mifepristone.

Medication prescribed:

Mifepristone is used alone or in combination with misoprostol (Cytotec) to end an early pregnancy. Early pregnancy means it has been 49 days or less since your last menstrual period began. Mifepristone is in a class of medications called antiprogestational steroids. It works by blocking the activity of progesterone, a substance your body makes to help continue pregnancy.

How should this medicine be used:

Mifepristone comes as a tablet to take by mouth. It should be taken only in a clinic, medical office, or hospital under the supervision of a qualified doctor. You will take three tablets of mifepristone at one time on the first day. Two days later you must go back to your doctor. If your doctor is not certain that your pregnancy has ended, you will take two tablets of another medication called misoprostol. You may have vaginal bleeding for 9 to 30 days or longer. If your bleeding is heavy, you should call the emergency contact number. Fourteen days after taking mifepristone, you must go back to your doctor for an exam or ultrasound to make sure that the pregnancy has ended. Take mifepristone exactly as directed.

Other uses for this medicine:

Mifepristone is also sometimes used to end pregnancies that are greater than 49 days since your last menstrual period; as an emergency contraceptive after unprotected sexual intercourse ('morning-after pill'); to treat tumors of the brain, endometriosis (growth of uterus tissue outside the uterus), fibroids (noncancerous tumors in the uterus); or to induce labor (to help start the birth process in a pregnant woman). Talk to your doctor about the possible risks of using this drug for your condition.

Special precautions:

Before taking mifepristone,
tell your doctor if you are allergic to mifepristone; misoprostol (Arthrotec, Cytotec); other prostaglandins such as alprostadil, carboprost tromethamine (Hemabate), dinoprostone (Cervidil, Prepidil, Prostin E2), epoprostenol (Flolan), latanoprost (Xalatan), treprostinil (Remodulin); or any other medications.
do not take mifepristone if you are taking any of the medications listed in the IMPORTANT WARNING section or corticosteroids such as beclomethasone (QVAR inhaler), betamethasone (Celestone), budesonide (Entocort, Pulmicort), cortisone (Cortone), dexamethasone (Decadron, Dexpak, Dexasone, others), fludrocortisone (Floriner), flunisolide (AeroBid); fluticasone (Advair, Flovent), hydrocortisone (Cortef, Cortenema, Hydrocortone), methylprednisolone (Medrol, Meprolone, others), prednisolone (Prelone, others), prednisone (Deltasone, Meticorten, Sterapred, others), and triamcinolone (Aristocort, Azmacort).
tell your doctor what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: amiodarone (Cordarone, Pacerone); astemizole; benzodiazepines such as alprazolam (Xanax), diazepam (Valium), midazolam (Versed), or triazolam (Halcion); buspirone (BuSpar); calcium channel blockers such as amlodipine (Norvasc), diltiazem (Cardizem, Dilacor, Tiazac, others), felodipine (Lexxel, Plendil), nifedipine (Adalat, Procardia), nisoldipine (Sular), nitrendipine , or verapamil (Calan, Isoptin, Verelan); carbamazepine (Tegretol); chlorpheniramine (antihistamine in cough and cold products); cholesterol-lowering medications (statins) such as atorvastatin (Lipitor), cerivastatin , lovastatin (Mevacor), or simvastatin (Zocor); cimetidine (Tagamet); cisapride; clarithromycin (Biaxin, Prevpac); cyclosporine (Neoral, Sandimmune); dicloxacillin; erythromycin (E.E.S., EM-Mycin, Erythrocin); fluoxetine (Prozac, Sarafem); fluvoxamine (Luvox); haloperidol; furosemide; HIV protease inhibitors such as indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir), or saquinavir (Fortovase, Invirase); itraconazole (Sporanox); ketoconazole (Nizoral); methadone (Dolophine, Methadose); nefazodone (Serzone); phenobarbital (Luminal, Solfoton); phenytoin (Dilantin); pimozide (Orap); propranolol (Inderal); quinidine; quinine; rifampin (Rifadin, Rimactane); rifabutin (Mycobutin); tacrolimus (Prograf, Protopic); tamoxifen (Nolvadex); trazodone; troleandomycin (TAO); verapamil (Calan, Covera, Isoptin, Verelan, others); or vincristine (Vincasar). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
tell your doctor what herbal products you are taking, especially St. John's wort.
tell your doctor if you have or have ever had any of the conditions listed in the IMPORTANT WARNING section or any of the following: diabetes (high blood sugar); high blood pressure; porphyria (an inherited blood disease that may cause skin or nervous system problems); adrenal failure (problems with your adrenal glands); or heart, kidney, liver, or lung disease
tell your doctor if you have an intrauterine device (IUD) in place. It must be taken out before you take mifepristone.
tell your doctor if you are breast-feeding. You may need to stop breast-feeding for a few days after taking mifepristone.
if you are having surgery, including dental surgery, tell the doctor or dentist that you have taken mifepristone.
you should know that mifepristone may make you dizzy. Do not drive a car or operate machinery until you know how this medication affects you.
tell your doctor if you smoke 10 or more cigarettes a day or if you have a history of heavy smoking.
you should know that after ending a pregnancy with mifepristone, you can become pregnant again right away, even before your period returns. If you do not want to become pregnant again, you should begin using birth control as soon as this pregnancy ends or before you start having sexual intercourse again.
tell your doctor if you are not able to quickly get to a medical facility which can provide emergency treatment if you should need it after taking mifepristone.

Special dietary instructions:

Do not take mifepristone with grapefruit juice. Talk to your doctor about drinking grapefruit juice after taking this medication.

If I forget a dose:

You will only take mifepristone in your doctor's office or clinic, so you do not have to worry about forgetting to take a dose at home.

What side effects:

Mifepristone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
vaginal bleeding or spotting
cramps
pelvic pain
vaginal burning, itching, or discharge
upset stomach
vomiting
diarrhea
headache
tiredness
difficulty falling asleep or staying asleep
anxiety
back or leg pain
Some side effects can be serious. The following symptom is uncommon, but if you experience it, or those listed in the IMPORTANT WARNING section, call your doctor immediately:
vaginal bleeding for more than 30 days
Mifepristone may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

What storage conditions:

Your doctor will store the medication in his or her office.

In case of overdose:

In case of overdose, call your local poison control center. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
dizziness
fainting
blurred vision
upset stomach
tiredness
weakness
shortness of breath
fast heart beat

Other information:

You should get mifepristone only from a doctor and use this medication only while under the care of a doctor. You should not buy mifepristone from other sources, such as the Internet, because you would bypass important safeguards to protect your health.
You must keep all appointments with your doctor, especially those appointments 2 and 14 days after taking mifepristone, to make sure that you are well and that the pregnancy has ended.
Do not let anyone else take your medication.